Fibroid Ablation Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01226290
• Date of registration: 20/10/2010
• Prospective Registration: Yes
• Primary sponsor: Gynesonics
• Public title: Fibroid Ablation Study FAST-EU
• Scientific title: Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
• Date of first enrolment: January 2011
• Target sample size: 51
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01226290
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Mexico, Netherlands, United Kingdom

Contacts

• Name: David Toub, MD
• Affiliation: Gynesonics

Key inclusion & exclusion criteria

Inclusion Criteria:

- 28 years of age or older

- Regular, consistent menstrual cycles

- History of excessive bleeding

- One Menstrual Pictogram score = 120 during a one-month screening period

- Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity
Subscale (SSS) score = 20

- Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc

- At least one fibroid must indent the endometrium

- Subject is not at material risk for pregnancy.

- Subject is willing to maintain use or non-use of hormonal contraception

- Subject is willing to have uniform maintenance (use or non-use) of any
antifibrinolytic or nonsteroidal anti-inflammatory agents

Exclusion Criteria:

- Subserosal fibroids with bulk symptoms

- Presence of type 0 intracavitary fibroids

- Any Target Fibroid > 5 cm in maximum diameter with a volume > 82.4cc

- Any fibroid that obstructs access of the VizAblate probe

- Postmenopausal by history

- Desire for current or future fertility

- Hemoglobin < 6 g/dl

- Pregnancy

- Evidence of disorders of hemostasis

- Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable
progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective
progesterone receptor modulator (SPRM)

- Short-term use of hormonal medication for management of bleeding

- Evidence for current cervical dysplasia

- Endometrial hyperplasia

- Confirmed abdominal / pelvic malignancy within the previous five years

- Active pelvic infection

- Clinically significant adenomyosis

- Previous uterine artery embolization. Previous surgical or ablative treatment for
fibroids or menorrhagia within previous 12 months

- Current use of anticoagulant therapy

- Need for emergency surgery to treat fibroid symptoms

- Concomitant intrauterine polyps > 1.0 cm

- Contraindication to MRI

- Renal insufficiency

- Uncontrolled hypertension lasting 2 years or more

- One or more treatable fibroids that are calcified

- Chronic pelvic pain

- Presence of an extrauterine pelvic mass

- Presence of a tubal implant for sterilization

- Previous pelvic irradiation

- Endometrial cavity length < 4.5 cm



Age minimum: 28 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Uterine Fibroids

Menorrhagia

Leiomyoma

Intervention(s)

Device: VizAblate System

Primary Outcome(s)

Mean percentage change in target fibroid perfused volume [Time Frame: 3 months]

Secondary Outcome(s)

Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire [Time Frame: baseline through 12 months]

Return to normal daily activity [Time Frame: 2 weeks or until returned to normal activity]

Percentage reduction in Menstrual Pictogram score [Time Frame: baseline through 12 months]

Number of adverse events [Time Frame: procedure through 12 mo]

Rate of surgical reintervention for menorrhagia [Time Frame: through 12 months]

Secondary ID(s)

CL02413

Source(s) of Monetary Support

Please refer to primary and secondary sponsors